| Product Description | UPN # | GTIN | Lot/Batch # | Expiration Date Range |
| HURRICANE Rx DILATION
BALLOON 4MM 2CM |
M00545890 | 08714729283805 | 25509445, 25536219, 25612668, 25649812, 25704208 | 4/13/2022 to
6/13/2022 |
| HURRICANE Rx DILATION
BALLOON 4MM 4CM |
M00545900 | 08714729283812 | 25326198, 25344165, 25344168, 25366542, 25366543, 25379240, 25379241, 25392546, 25447687, 25447688, 25447689, 25447690, 25447691, 25447692, 25453103, 25453105, 25453108, 25466435, 25468596, 25468597, 25471588, 25479171, 25479176, 25479177,
25479178, 25479521, 25481983, 25481984, 25481985, 25481986, 25497466, 25497467, 25497468, 25506678, 25509440, 25509446, 25509447, 25509450, 25518274, 25518305, 25518314, 25533944, 25536416, 25536680, |
2/7/2022 to
6/27/2022 |
The Food and Drug Administration (FDA) warns all healthcare professionals and establishments on the voluntary recall of affected lots of Hurricane™ RX Biliary Balloon Dilatation Catheters with FDA registration number, DVR-8150, manufactured by Boston Scientific Corporation, imported and distributed by Boston Scientific Philippines, Inc.:
| HURRICANE Rx DILATION
BALLOON 4MM 4CM |
M00545900 | 08714729283812 | 25536860, 25543967, 25543969, 25571363,
25575934, 25575935, 25576717, 25576718, 25576719, 25576720, 25576721, 25576769, 25611564, 25612669, 25612670, 25612671, 25612673, 25612674, 25623377, 25623378, 25623379, 25623380, 25623381, 25623382, 25623383, 25623384, 25640115, 25649813, 25649816, 25678821, 25678826, 25678831, 25678836, 25680096, 25704209, 25704210, 25704211, 25704212, 25704213, 25704214, 25704215, 25704216, 25739146, 25739147, 25739149, 25739150, 25771761, 25771762, 25771765 |
2/7/2022 to
6/27/2022 |
| HURRICANE Rx DILATION
BALLOON 6MM 2CM |
M00545910 | 08714729283829 | 25456946, 25497472, 25571369, 25623385, 25678822, 25739151 | 3/22/2022 to
6/20/2022 |
| HURRICANE Rx DILATION
BALLOON 6MM 4CM |
M00545920 | 08714729283836 | 25305803, 25326193, 25326194, 25326195, 25326199, 25334817, 25334818, 25366544, 25366545, 25366546,
25366547, 25392549, 25392551, 25392553, 25392554, 25392555, 25397943, 25397944, 25447697, 25447698, 25453106, 25453109, 25461680, 25466436, 25468598, 25472425, 25475235, 25475236, 25479172, 25479173, 25479179, 25481987, 25481988, 25481989, 25481990, 25481991, |
2/2/2022 to
6/27/2022 |
| HURRICANE Rx DILATION
BALLOON 6MM 4CM |
M00545920 | 08714729283836 | 25497469, 25497470, 25497473, 25497474, 25497475, 25509412,
25509413, 25509414, 25509451, 25509452, 25509453, 25518276, 25518306, 25518307, 25518315, 25518316, 25536681, 25536739, 25536740, 25543970, 25543971, 25543972, 25543973, 25571370, 25571373, 25576770, 25576771, 25576772, 25576773, 25576881, 25576882, 25576883, 25576884, 25576885, 25608762, 25623386, 25623387, 25623388, 25623389, 25623390, 25623391, 25623392, 25623393, 25623394, 25623395, 25623396, 25623397, 25623398, 25649814, 25649817, 25649820, 25649821, 25649825, 25649826, 25649830, 25649831, 25678823, 25678827, 25678832, 25678837, 25680097, 25704217, 25704218, 25704219, 25704220, 25704221, 25704222, 25704223, 25739152, 25739153, 25739154, 25739155, 25739157, 25739158, 25771773 |
2/2/2022 to
6/27/2022 |
| HURRICANE Rx DILATION
BALLOON 8MM 2CM |
M00545930 | 08714729283843 | 25509441, 25536741, 25644951, 25649190, 25650286, 25651334,
25654287 |
4/13/2022 to
5/31/2022 |
| HURRICANE Rx DILATION
BALLOON 8MM 4CM |
M00545940 | 08714729283850 | 25317077, 25326196, 25326220, 25326221, 25326222, 25334819, 25344169, 25366548, 25366549, 25392556, 25392557, 25397079, 25447693, 25447694, | 2/4/2022 to
6/30/2022 |
| HURRICANE Rx DILATION
BALLOON 8MM 4CM |
M00545940 | 08714729283850 | 25453104, 25453107, 25453110, 25466437, 25468599, 25471589, 25471590, 25475234, 25479174, 25479175,
25479520, 25479580, 25481992, 25497051, 25497052, 25502738, 25509415, 25509416, 25509417, 25509418, 25509419, 25509442, 25509448, 25509454, 25509546, 25518277, 25518278, 25518317, 25518318, 25536682, 25536742, 25536743, 25543975, 25543976, 25543977, 25543978, 25543979, 25544020, 25571371, 25571374, 25596599, 25602458, 25608760, 25612672, 25649815, 25649818, 25649822, 25649823, 25649827, 25649828, 25649832, 25649833, 25678824, 25678828, 25678829, 25678833, 25678834, 25678838, 25680098, 25680099, 25704224, 25704225, 25704226, 25704227, 25704228, 25704229, 25739159, 25739160, 25739161, 25739162, 25739163, 25739164, 25739165, 25739166, 25739167, 25739168, 25788242, 25789369, 25789801 |
2/4/2022 to
6/30/2022 |
| HURRICANE Rx
DILATION BALLOON 10MM 2CM |
M00545950 | 08714729283867 | 25471587, 25571372,
25588303, 25673064 |
3/28/2022 to
6/6/2022 |
| HURRICANE Rx
DILATION BALLOON 10MM 4CM |
M00545960 | 08714729283874 | 25334980,25344170, 25344171, 25366550, 25378999, 25397945, 25397950, 25447685, 25447695, 25447696, 25461681, 25464817,
25466438, 25471591, 25471592, 25484487, 25493901, 25497471, 25497476, 25509443, 25509444, 25509449, 25518279, 25518308, 25518309, 25536683, 25544022, 25544023, 25544024, 25544025, 25571375, 25602323, 25608761, 25640116, 25640117, 25644834, 25649819, 25649824, 25649829, 25649834, 25678825, 25678830, 25678835, 25678839, 25678880, 25680560, 25704230, 25704231, 25704232, 25739169, 25739170 |
2/8/2022 to
6/20/2022 |
Figure 1. Hurricane™ RX Biliary Balloon Dilation Catheter
Boston Scientific Corporation initiated the voluntary recall of the above-mentioned specific lots/batches of Hurricane™ RX Biliary Balloon Dilatation Catheters in response to an increase in complaints of the RX tunnel component (black sheath) detaching from the catheter shaft. Investigation has shown this is due to a lower bond strength of the tunnel component which may lead to detachment.
The most common potential consequences related to a detached RX tunnel component would be a prolonged procedure duration while the device is exchanged. The most severe potential injury would include hemorrhage and/or tissue damage/perforation to the common bile duct during the retrieval of a detached RX tunnel component.
In light of the foregoing, all concerned healthcare professionals, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of Hurricane™ RX Biliary Balloon Dilatation Catheters.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No.2021-0401